Design Quality Engineer in Oberdorf
Design Quality Engineer - Oberdorf, Switzerland
Jocelyn Blackham is recruiting for a Design Quality Engineer to join a global medical device company at their site based in Oberdorf on a contract basis for 12 months.
The main purpose of the role will be to:
- Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
- Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
- Perform Gage R&R studies.
- Conduct and lead design verification and validation activities.
- Conduct and lead design / process failure mode effects and analysis.
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
- Provide leadership in the understanding of medical device regulations to other disciplines.
Further responsibilities will include:
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Accountability for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
- Providing a clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline with a previous experience in related field is required.
- A working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
- Previous Quality Engineering experience is preferred.
- Experience in an Medical Device regulated environment.
- Strong quality engineering skills with a proven track record in design. verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
- English language skills are essential, German skills are desirable.
This is an excellent opportunity to join a world leader in the medical device field.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 417276793 or email email@example.com. Please quote reference QLS44199 in all correspondence.